NCT00815542

Brief Summary

When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term. The study will be a prospective randomised trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
3.4 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

December 25, 2008

Last Update Submit

March 22, 2012

Conditions

Cervical Ripening

Outcome Measures

Primary Outcomes (1)

  • Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.

    during induction of labor, delivery and early post partum

Secondary Outcomes (1)

  • patients satisfaction

    induction of labor, delivery and early postpartum

Study Arms (2)

double balloon catheter

ACTIVE COMPARATOR

Cervical ripening by double balloon catheter

Device: double balloon catheter

prostaglandins E2

PLACEBO COMPARATOR

cervical ripening using prostaglandins E2

Drug: prostaglandins E2

Interventions

double balloon catheterDEVICE

cervical ripening using double balloon catheter

double balloon catheter
prostaglandins E2DRUG

prostaglandins E2 - Intravaginal Propess for 24 hours

prostaglandins E2

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • normal pregnancy, well dated, at term
  • un ripened cervix

You may not qualify if:

  • previous cesarean section
  • multiple pregnancy
  • intra uterine growth restricted fetus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medial Center

Kfar Saba, Israel

Location

Study Officials

  • Tal Biron - Shental, MD

    Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Biron - Shental, MD

CONTACT

972-577-482716Biront@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2008

First Posted

December 30, 2008

Study Start

June 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

IL(1)